Dose of Spinal Manipulation for Chronic Low Back Pain - Tabular View

Tracking Information

First Received Date ^ICMJE

September 12, 2006

Last Updated Date

November 19, 2009

Start Date ^ICMJE

March 2007

Estimated Primary Completion Date

March 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Modified Von Korff Pain Scale for low back pain [ Time Frame: baseline 1&2, 6, 12, 18, 24, 39, 52 weeks ] [ Designated as safety issue: No ]
Modified Von Korff Disability Scale [ Time Frame: baseline 1&2, 6, 12, 18, 24, 39, 52 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Modified Von Korff Pain Scale for low back pain
Modified Von Korff Disability Scale

Change History

Complete list of historical versions of study NCT00376350 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Pain days [ Time Frame: baseline 1&2, 6, 12, 18, 24, 39, 52 weeks ] [ Designated as safety issue: No ]
Disability days [ Time Frame: baseline 1&2, 6, 12, 18, 24, 39, 52 weeks ] [ Designated as safety issue: No ]
Low back pain unpleasantness [ Time Frame: baseline 2, 6, 12, 18, 24, 39, 52 weeks ] [ Designated as safety issue: No ]
Fear avoidance beliefs [ Time Frame: baseline 2, 6, 12, 18, 24, 39, 52 weeks ] [ Designated as safety issue: No ]
General health status/QoL [ Time Frame: baseline 2; 12, 24, 39, 52 weeks ] [ Designated as safety issue: No ]
Patient satisfaction [ Time Frame: 12 wk ] [ Designated as safety issue: No ]
Healthcare utilization [ Time Frame: baseline 2; 6, 12, 18, 24, 39, 52 weeks ] [ Designated as safety issue: No ]
Objective measures [ Time Frame: Baseline 2, 6 wk ] [ Designated as safety issue: No ]
Bias monitoring [ Time Frame: baseline 1&2; 6, 12, 18, 24, 39, 52 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Pain days
Disability days
Low back pain unpleasantness
Fear avoidance beliefs
General health status/QoL
Patient satisfaction
Healthcare utilization
Objective measures
Bias monitoring

Descriptive Information

Brief Title ^ICMJE

Dose of Spinal Manipulation for Chronic Low Back Pain

Official Title ^ICMJE

Dose-Response/Efficacy of Manipulation for Chronic LBP

Brief Summary

This study will determine the number of visits to a chiropractor for spinal manipulation, light massage, and ultrasound necessary for optimal relief of chronic low back pain. The study will also determine the effectiveness of spinal manipulation.

Detailed Description

Study Phase

Phase II, Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Low Back Pain

Intervention ^ICMJE

Procedure: Spinal Manipulation
Procedure: Light Massage
Procedure: Pulsed Ultrasound

Study Arms / Comparison Groups

Experimental: High dose spinal manipulation + ultrasound
Experimental: Moderate dose manipulation + low dose massage + ultrasound
Experimental: low dose spinal manipulation + moderate dose massage + ultrasound
Other: high dose massage = ultrasound

Publications *

Haas M, Groupp E, Kraemer DF. Dose-response for chiropractic care of chronic low back pain. Spine J. 2004 Sep-Oct;4(5):574-83.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

400

Estimated Completion Date

March 2011

Estimated Primary Completion Date

March 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Current episode of low back pain
mechanical origin
Threshold low back pain level

Exclusion Criteria:

Contraindications to spinal manipulation or massage
Complicating conditions that could confound clinical outcome
Prophylactic use of prescription medication
Health-related litigation, claims, or disability compensation

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Jonathan Levine

800-678-9072

jlevine@wschiro.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00376350

Responsible Party

Joseph Brimhall, Western States Chiropractic College

Study ID Numbers ^ICMJE

U01 AT001908, U01AT001908

Study Sponsor ^ICMJE

Western States Chiropractic College

Collaborators ^ICMJE

National Center for Complementary and Alternative Medicine (NCCAM)

Investigators ^ICMJE

Principal Investigator:

Mitchell Haas, DC, MA

Western States Chiropractic College

Information Provided By

Western States Chiropractic College

Verification Date

November 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP